Updated on 21 December 2015
Norway-based Serendex Pharmaceuticals A/S has entered into a non-binding term sheet with a pharma company regarding Serendex's possible future grant of an exclusive license to the compound molgramostim in Japan. Due to a confidentiality undertaking, Serendex Pharmaceuticals is restricted from disclosing the identity of the partner.
Provided a definitive license agreement is made between the two companies upon terms identical to the ones set out in the term sheet, Serendex will receive up to $11.5 million in milestone payments and be entitled to royalties on future sales in Japan. The agreement would render the strategic partner license holder of Molgradex for the treatment of PAP in Japan and also contain a license option for other indications. The Japanese market represents approximately 10% of the global market for PAP.
"We are thrilled about this potential agreement with the strategic partner. It proves in our view that there is a real demand and a substantial global market for our future product and it reflects our dedication to developing an inhalation treatment for PAP patients that have no treatment options today," said Kim Arvid Nielsen, CEO of Serendex.
Upon achievement of certain future milestones, payments will become payable by the strategic partner. However, the potential license agreement is not expected to have a significant cash effect on Serendex cash flow in 2016 and Q1-Q3 of 2017.
The significant future milestones relate to completion of a successful clinical study in Japan (expected in Q4 2017), submission for marketing authorization in Japan (expected in 1H 2018) and achievement of marketing authorization in Japan (expected in 1H 2019). Furthermore, Serendex will under the potential license agreement be entitled to royalty payments based on accumulated net sales in Japan.